MAUDE Adverse Event Report: MPRI CAPSURE VDD-2 LEAD; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number	5038S-58
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the patient developed an infection.It was also noted that the pacing lead had a lead failure.The pacing lead was cut capped and partially explanted.Only the pacing lead tip remains in patient.The implantable pulse generator (ipg) was explanted.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was further reported that a leadless ipg was placed approximately one month later.

• Brand Name: CAPSURE VDD-2 LEAD
• Common Device Name: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 20555665
• Report Number: 2649622-2024-28844
• Device Sequence Number: 8886287
• Product Code: DXY
• UDI-Device Identifier: 00681490122931
• UDI-Public: 00681490122931
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/20/2006
• Device Model Number: 5038S-58
• Device Catalogue Number: 5038S-58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/25/2024
• Date Device Manufactured: 05/03/2005
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: W2DR01 IPG
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male